Rectal Indomethacin to Prevent Post ESWL-pancreatitis

Pancreatitis Clinical Trial

— RIPEP  

Official title:

Rectally Administered Indomethacin to Prevent Post-ESWL-pancreatitis (RIPEP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797067
• Other study ID #: ESWL-pancreatitis
• Status: Completed
• Phase: Phase 4
• Start date: May 31, 2016
• Est. completion date: August 2021

Study information

• Verified date: March 2022
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether rectal indomethacin reduces the incidence of post-ESWL pancreatitis.

Description:

It is a prospective, double-blind, randomized controlled trial. Patients with painful chronic pancreatitis and pancreatic stones (> 5 mm in diameter) who are treated with ESWL at Changhai Hospital will be randomly allocated to indomethacin or placebo therapy before the procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1370
• Est. completion date: August 2021
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• any patient with chronic pancreatitis and pancreatic stones (> 5 mm in diameter) undergoing P-ESWL

• at least 18 years old

• provides informed consent

Exclusion Criteria:

• readmitted to the hospital during the enrollment of the study

• contraindications to ESWL

• suspected or established malignancy

• pancreatic ascites

• receiving NSAIDs within 7 days

• contraindication to NSAIDs (including gastrointestinal hemorrhage within 4 weeks or renal dysfunction with serum creatinine >120 µmol/L)

• presence of coagulopathy or received anticoagulation therapy within 3 days

• acute pancreatitis within 3 days

• known active cardiovascular or cerebrovascular disease

• pregnant or breastfeeding women

• without a rectum (ie, status post-total proctocolectomy)

Related Conditions & MeSH terms

• Pancreatitis

Intervention

Drug:
• indomethacin suppository
100mg rectal indomethacin 30min before ESWL
• Glycerin Suppository
30min before ESWL

Locations

Country	Name	City	State
China	Shanghai Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relative Risks in the Subgroup of Potential Risk Factors for Post -ESWL Pancreatitis Will be Assessed by SPSS(Statistical Product and Service Solutions,a Statistical Software).	Potential risk factors including sex, steatorrhea, pancreas divisum, frequent attack of acute pancreatitis (= 1/year), diabetes, CBD(common bile duct) stenosis, alcohol consumption, multiple stones, position (the 30°-right supine position) and shock wave frequency =100/min.These will be assess to determine whether the treatment effect differ in these pre-specified factors.	up to 1 months
Primary	the Incidence of Post-ESWL Pancreatitis	Patients were identified as post-ESWL pancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.	up to 1 months
Secondary	the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications	Asymptomatic hyperamylasemia was defined as an increase in serum amylase compared with pre-ESWL levels and beyond the upper limit of the normal range but showing no related symptoms. Serum amylase will be measured in all study patients at 3 and 24 hours after the procedure and subsequently at clinical discretion.; Other post-ESWL complications including bleeding, infection, steinstrasse and perforation.; Bleeding is related to clinical evidence,the level of hemoglobin ( measured at 24 hours after the procedure and at clinical discretion) and treatments.; Infection is related to temperature and treatment. Steinstrasse is related to abdominal pain degree and the combination of other complications.; Perforation is related to treatment.	up to 1 months
Secondary	the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP(Endoscopic Retrograde Cholangiopancreatography )	Post-ESWL complications are also stratified as mild, moderate and severe depending mainly on the length of hospitalization and the need for invasive treatment.	up to 1 months